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Full Stability Study Design Assume that a stability study includes three factors: batch, strength (denoted S1, S2, and S3 in what follows), and packaging size (denoted P1, P2, and P3). Each value of a factor is normally referred to as level. Therefore, if there are four packaging sizes, the factor called packaging size has four levels. It should be noted that the FDA requires at least three batches and consequently the batch factor will have three levels. If the other two factors have three levels each, then the required number of experiments is 27. Table 2 shows the 27 experiments that should be performed at each point in time. The number of combinations, C, can be readily calculated by multiplying the number of levels of each factor:



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A primary risk is a self-initiating source of risk, usually related directly to the initial list of project elements. A secondary risk arises as a consequence of a primary risk, or as a consequence of implementing a control or a treatment response. A secondary response is a response to a secondary risk. For example, in some circumstances a fire might be a primary risk, with water damage and structural collapse as associated secondary risks. Where possible, secondary risks and responses should be embedded in the primary response, as this often simplifies the subsequent analysis. The use of scenarios provides one way of doing this. However, it is not always possible, nor is it always desirable, to embed secondary risks and responses. This is the case particularly if the secondary risk or its associated responses may themselves have major consequences, or if they differ in significant ways from the initiating primary risks. The same risk and response description worksheets may be used for secondary risks and responses. A structure diagram is a useful way of summarizing the relationships, including the project items, primary risks and responses and secondary risks and responses, with their interconnections. Figure 6.7 shows an example adapted from Cooper and Chapman (1987).





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security tax, FICA, workmen s compensation, and other complexities Independent contractors are paid as vendors Note: The Internal Revenue Service requires that people who are paid as independent contractors work on their premises and have other clients Consult your accountant or tax attorney 5 Subcontractors are more motivated because they are sellers and you are the buyer They have a customer-service orientation, which is a welcome change from the attitude of resentment or indifference many employees seem to have toward the boss 6 Subcontractors provide their own equipment and office space, buy their own furniture, and pay their own utility bills Often subcontractors will have better equipment than you do, and as their client, you get the benefits of this equipment without buying it.

TABLE 14.3 Throughput from a point to point T1 line for various types of modalities Modality Type MRI CT CR Mammography File Size 130 KB 512 KB 7 MB 400 MB Throughput 150 165 175 176 Kbytes/s Kbytes/s Kbytes/s Kbytes/s

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Figure 9.3 plots this bound versus n, and also shows the magnitude of the computed (i.e., the true or actual) total error in the trapezoidal rule approximation, which is |T (n) I |. We see that the true error is always less than the bound, as we would expect. However, the bound is rather pessimistic. Also, the bound predicts

Figure 7.1 Cell-based simulation ow chart [5].

So subcontracting can actually reduce your overhead and capital costs, while hiring employees increases it, since you have to supply the employee with a fully equipped work space Outsource everything other than your core function, recommends Stephen M Polland in an article in Dan Kennedy s No BS Marketing Letter (December 1998, p 12) His advice includes replacing full- and part-time staffers with independent contractors or other entrepreneurs; leasing or renting rather than owning hard assets; and focusing on personal productivity and profitability Where do you find outsourcing help Be creative When my longtime staff secretary quit to take another job, I wondered where I would find another assistant A colleague suggested that instead of hiring a fulltime secretary, I find a typing/word processing/secretarial service to handle my needs I looked in the local paper and Yellow Pages and called several services.

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